Do you know what the FDA means when it issues a Class 1 recall? It is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” The Class1 recall is the FDA’s strongest and most urgent classification of a problem with a drug, treatment, or device that falls under the scrutiny of the FDA.
In a press release dated May 2, 2013, Medtronics, Inc., a medical technology corporation (a member of the NYSE) issued an Urgent Medical Device Correction notification after receiving a Class 1 recall notification from the FDA for its Deep Brain Stimulator. The recall came in February, the public learned about it in May.
The Deep Brain Stimulator (DBS) is one of many biotechnical medical devices manufactured by Medtronics for use in the treatment of cardiovascular and neurological diseases, diabetes, and other medical conditions. “DBS uses a surgically implanted medical device, similar to a pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain.” (Medtronics PR, 5/2) The defective device is used in the treatment of Parkinson’s disease and other neurological conditions. There is a “potentially life-threatening flaw” having to do with the wires, or leads, on the end of the piece being inserted in the brain. See the Medtronics, Inc. press release for more details.
I love how the press release states that the “lead replacement may be required or optimal therapy may not be achieved.” They make it sound as simple as replacing a cracked screw cap or putting in new batteries. Not something that might warrant a FDA Class1 recall!
As with many recalls, there are lots of questions we should be asking. Did this recall notice get shared with Parkinson’s patients and their families? What procedures does the FDA use to monitor a company once a major recall notice has been issued? And, how is Medtronic following up with each of the 1,598 devices distributed between 04/2006 and 02/28/2013?
Have people been at risk since 2006? Did someone just discover the flaw some 7 years later? If I read the FDA recall correctly, remember I’m a lawyer not a doctor, the severity of the recall indicates that there is a reasonable probability of serious adverse health consequences or death. A little ‘setscrew’ on electrode 3 could cause a problem sufficient to severely damage or kill the patient being treated.
It’s not without irony that I share this self-descriptor from Medtronics;
“Medtronic, Inc. is engaged in medical technology – alleviating pain, restoring health, and extending life for millions of people worldwide.”
I’m sure the people at Medtronics, like many other cutting edge technology companies, are doing wonderful work. They are creating machines to treat diseases our parents never heard of, or hoped to survive. Lives are being saved, diseases lessened in severity, and people have new hope for a better, longer life.
But it is scary to realize that even the most sophisticated and medically advanced treatments can be dependent on the smallest piece of equipment. Our lives hang in the balance regardless of how smart our doctors are or how sophisticated the equipment used to treat our bodies. As with all of life, our health is a balancing act. We want to go about our day-to-day tasks with a sense of security and a lack of fear—trusting the experts in charge of our medical health. But we have to remain vigilant about who we allow to treat us, how they do their job, what medications we’re given and what kind of equipment we’re being treated with.